Exercise and RIC and TCD

Stroke, Acute Clinical Trial

Official title:

The Effects of Acute Exercise and Remote Ischaemic Conditioning (RIC) on Cerebral Blood Flow Velocity in Patients With Ischaemic Stroke and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968068
• Other study ID #: STH20750
• Status: Completed
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The first week after a stroke is a particularly important time, as improving blood flow may limit secondary ischaemic damage to the brain and help reduce the overall burden neurological injury and future disability. Small studies in patients with stroke have shown that moderate aerobic exercise increases blood flow to the brain, however, no studies have evaluated the safety of aerobic exercise within the first week after stroke, nor whether it results in changes to cerebral blood flow. Remote ischaemic conditioning (RIC) is when ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. These changes often result in improved blood supply to various areas of the body. The use of RIC in the acute period after stroke is currently being investigated in a number of large randomised controlled trials e.g. RECAST, RESIST, however, our understanding of how RIC actually works is incomplete. Importantly, there is scarce data on the acute effects of RIC on cerebral blood flow (CBF), a potentially pivotal mechanism behind its effects. We propose an exploratory study to evaluate whether it is feasible, acceptable and safe to undertake low and moderate intensity aerobic exercise or remote ischaemic conditioning (RIC) in patients during the acute period after stroke, and whether either of these interventions result in changes to cerebral blood flow velocity (CBFv) in the major cerebral arteries. We will compare any changes to those in a cohort of healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (age > 18) patients who have suffered acute ischaemic stroke between 2-7 days previously, or healthy adult (>18 years).
• Ability to provide written informed consent
• Ability to mobilise lower body limbs (at least one leg)
• Ability to comply with study procedures in the opinion of the treating physician.

Exclusion Criteria:

• Haemorrhagic Stroke
• Ischaemic stroke < 2 days or >10 days
• Disability preventing lower extremity cycling
• New York Heart Failure Classification stage III/IV
• History of ischaemic stroke
• Current diagnosis of cancer
• Resting Blood pressure > 180 / 100 mmHg
• Clinically unstable
• History or presence of significant peripheral vascular disease in the upper limbs.
• History or presence of complex neuropathic pains or peripheral neuropathy in the arms.
• Presence of lymphoedema in the arms.
• Presence of skin ulceration to the arms.
• Uncontrolled arrhythmia, hypertension, diabetes or angina.
• Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Procedure:
• Exercise Procedure
Patients will undergo 30 minutes of light-moderate intensity leg cycling, using the Letto-2 (Motomed, UK) in the semi-supine position.
• Remote Ischaemic Conditioning
Patients will undergo 4 cycles of upper limb RIC using a blood pressure cuff. Each cycle will involve inflating the blood pressure cuff to 200 mmHg for five minutes around the upper arm, followed by a period of relaxation of the cuff for a further 5 minutes. The total RIC treatment time will take 40 minutes.

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS FT	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Incidences of RICTreatment-Emergent Adverse Events.	Safety of the RIC intervention will be assessed by measuring the Number of Adverse Events experienced by participants that are related to the RIC intervention.	48 hours
Primary	Number of Incidences of Exercise Treatment-Emergent Adverse Events.	Safety of the exercise intervention will be assessed by measuring the Number of Adverse Events experienced by participants that are related to the exercise intervention.	48 hours
Primary	Number of participants reporting RIC associated discomfort on a likert scale	Reported grade of discomfort associated with RIC will be measured on a likert scale of 0-5, 1 being very uncomfortable to 5 being very comfortable. Acceptance of RIC will be defined as an average score of >3/5 on the likert scale.	48 hours
Primary	Number of participants reporting exercise associated discomfort on a likert scale	Reported grade of discomfort associated with exercise will be measured on a likert scale of 0-5, 1 being very uncomfortable to 5 being very comfortable. Acceptance of exercise will be defined as an average score of >3/5 on the likert scale.	48 hours
Primary	% of RIC intervention completed and recorded	Feasibility of RIC will be defined as >80% of the intervention being completed and recorded.	48 hours
Primary	% of exercise intervention completed and recorded	Feasibility of exercise will be defined as >80% of the intervention being completed and recorded.	48 hours
Secondary	Change from baseline in cerebral blood flow velocity.	Cerebral blood flow velocity will be measured using Transcranial Doppler (TCD).	48 hours